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________________________________________ From: Graham Crawley
<[FOI #814619 email]> Sent: Wednesday, December 8,
2021 3:31:25 PM To: MHRA Customer Services Subject: Freedom of Information
request - How many deaths are too many with Pfizer BNT162B2 in order to
halt deployment? Dear Medicines and Healthcare Products Regulatory Agency,
Pfizer has published the following: 5.3.6 CUMULATIVE ANALYSIS OF
POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2)
RECEIVED THROUGH 28-FEB-2021 1. When did the MHRA become aware of this
report? 2. Up to end February 2021 Pfizer had been informed of 1223 deaths
following administration of their vaccine BNT162B2 3. Up to 24/11/2021
there have been 628 deaths reported to the MHRA Yellow Card adverse
reaction reporting systems for Pfizer BNT162B2 vaccine 4. How many deaths
following inoculation with Pfizer BNT162B2 will the MHRA consider a
threshhold upon which you will suspend or halt the deployment of BNT162B2
in the UK? Yours faithfully, Graham Crawley
------------------------------------------------------------------- Please
use this email address for all replies to this request:
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Our Reference: CSC 80228

Dear Graham Crawley

Thank you for your email.

We have reviewed your enquiry and this has been passed on to our Vigilance Risk Management of Medicines experts.

Should you have any other questions or requests please feel free to call us on 0203 080 6000 or email at [MHRA request email]

Our opening hours are Mon - Fri 9am to 5pm (excluding UK Public Holidays)
Kind regards

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
gov.uk/mhra
Stay connected

For information on how the Agency uses your personal data and your data protection rights, please see our three centres' Privacy Notices: MHRA, CPRD and NIBSC

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Dear Enquirer

Thank you for your email.

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) role is
to continually monitor safety during widespread use of a vaccine. We have
in place a proactive strategy to do this. We also work closely with our
public health partners in reviewing the effectiveness and impact of the
vaccines to ensure the benefits continue to outweigh any possible side
effects.

Part of our monitoring role includes reviewing reports of suspected side
effects. Any member of the public or health professional can submit
suspected side effects through the Yellow Card scheme. The nature of
Yellow Card reporting means that reported events are not always proven
side effects. Some events may have happened anyway, regardless of
vaccination. This is particularly the case when millions of people are
vaccinated (over 130 million COVID-19 vaccines have been given in the UK
alone to date), including elderly people and people who have underlying
illness.

The document you refer to has not been submitted to the MHRA. However, we
regularly review safety information from the COVID-19 vaccine
manufacturers and are in regular contact with other regulators across the
world to exchange safety data on the COVID-19 vaccines. This information
is considered in our assessments alongside the UK data, to ensure that the
balance of benefits and risks of the COVID-19 vaccines remains favourable.

Information about our analysis of safety data regarding COVID-19 vaccines
is published in our weekly summary of COVID-19 vaccine Yellow Card reports
which is available at:
[1]https://www.gov.uk/government/publicatio....

Please be assured that the MHRA continues to closely monitor the safety of
the COVID-19 vaccines used in the UK.

Kind regards,

Pharmacovigilance Service Team 

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Email: [2][email address]
Stay connected: [3]mhra.gov.uk/stayconnected

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